title: White paper: an outlook on U.S. biosimilar competition.
abstract: The pharmaceutical industry is experiencing change in ways it hasn't ever before. One topic at the center of all of these changes is the U.S. biosimilars market. This report will provide updates and changes associated with biosimilar regulations in the U.S. Additionally, the paper will identify requirements for success, and the likely early entrants in the U.S. market.
authors.affiliation: Thomson Reuters, Portland, Maine, USA. andrew.bourgoin@thomsonreuters.com
authors.forename: A F
authors.initials: AF
authors.lastname: Bourgoin
authors.forename: B
authors.initials: B
authors.lastname: Nuskey
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D002986:Clinical Trials as Topic; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control; D010330:Patents as Topic; D009626:Terminology as Topic; D014481:United States
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Biologics Price Competition and Innovation Act; Biosimilar User Fee Act; Biosimilars; Patient Protection and Affordable Care Act